Immix Biopharma Awarded European Union Orphan Drug Designation For NXC-201 In AL Amyloidosis
Portfolio Pulse from Benzinga Newsdesk
Immix Biopharma, Inc. (NASDAQ:IMMX) has been granted the European Union Orphan Drug Designation (ODD) for NXC-201, a treatment for AL Amyloidosis. This designation offers 10 years of market exclusivity in the EU, access to centralized authorization, reduced fees, and other benefits. The U.S. prevalence of relapsed/refractory AL Amyloidosis is increasing by 12% annually, with an estimated 29,712 patients in 2023. The company believes NXC-201 could be a one-time treatment option for this condition, with a favorable tolerability profile and potential for expansion into other autoimmune diseases.
February 07, 2024 | 2:41 pm
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Immix Biopharma's receipt of the EU Orphan Drug Designation for NXC-201 could significantly enhance its market position in treating AL Amyloidosis, offering potential revenue growth and expansion into the EU market.
The Orphan Drug Designation by the EU for NXC-201 provides Immix Biopharma with several competitive advantages, including 10 years of market exclusivity, reduced regulatory fees, and access to centralized authorization. This designation is likely to positively impact the company's stock in the short term due to the potential for increased market penetration and revenue in the EU. The growing prevalence of AL Amyloidosis and the lack of satisfactory treatment options further underscore the significance of this development for Immix Biopharma.
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